Seattle Genetics Inc. (NASDAQ: SGEN) shares dipped on Monday following an update from the U.S. Food and Drug Administration (FDA). Essentially, the FDA granted Breakthrough Therapy Designation to Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphoma (PTCL).
Positive topline results of the firm’s Phase 3 Echelon-2 clinical trial were announced in October 2018, followed by the submission of a supplemental Biologics License Application to the FDA in November 2018.
Additional data from this late-stage trial will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting, December 1 to 4, 2018, in San Diego, California. Adcetris is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of PTCL. Currently, Adcetris is not approved for the frontline treatment of PTCL.
Ultimately, the FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions.
Clay Siegall, Ph.D., president and CEO of Seattle Genetics, commented:
Data from the ECHELON-2 phase 3 trial of ADCETRIS in combination with chemotherapy showed superior progression-free survival and overall survival versus the standard of care chemotherapy regimen, CHOP, in the treatment of frontline CD30-expressing peripheral T-cell lymphomas. This is the third Breakthrough Therapy Designation for ADCETRIS and supports our goal to make this therapy available to patients with newly diagnosed peripheral T-cell lymphomas as soon as possible. We look forward to presenting the data from our phase 3 ECHELON-2 trial at the upcoming ASH Annual Meeting.
Shares of Seattle Genetics were last seen down over 1% at $52.26, in a 52-week range of $47.75 to $84.37. The consensus analyst price target is $80.45.